ISMP Quarterly Action
Agenda: July - September, 1999
From the October 6, 1999 issue
One of the most important methods for preventing adverse
drug events is for organizations to be proactive by seeking
and using knowledge from other organizations that have already
experienced problems. To make a significant impact on error
prevention efforts, administrative staff and an interdisciplinary
committee at each practice site should review the following
agenda to prompt discussion, and then take the necessary action
to minimize adverse drug events in your facility. The following
selected items appeared in the ISMP Medication Safety Alert!
between July and September, 1999. Each item includes a description
of the problem, recommendations for safe medication practices,
and the issue number (in parentheses) to locate additional
information. The American Society of Health Care Risk Management
(ASHRM) provides the ISMP Quarterly Action Agenda to all its
members. A list of agenda items is also posted on our web
site (www.ismp.org), and, in many cases, product-related problems
can be visualized in the ISMP Medication Safety Alert! section
of our web site.
I. Look-alike/sound-alike drug names, ambiguous or
look-alike labeling and packaging
- Handwritten AVANDIA orders confused with COUMADIN
and PRANDIN (15, 18
Problem:Poorly handwritten orders for the new oral
antidiabetic agent for Type II diabetes, AVANDIA (rosiglitazone),
have been confused with the oral anticoagulant COUMADIN
(warfarin) and PRANDIN (repaglinide), also a drug for Type
II diabetes. Avandia and Coumadin are both available in
a 4 mg oral dosage form. Prandin is available in a 2 mg
tablet but the dose ranges up to 4 mg. These dose similarities
increase the risk of confusion.
Recommendation:Educate staff about the error potential
between these products, even if any of these drugs are not
on the formulary. Build alert flags into pharmacy computer
systems and use reminder labels on drug containers. Physicians
should provide written indications for medications with
each prescription and educate patients so they are aware
of the product name and know what to expect at the pharmacy.
- Ferrous sulfate confusion (16)
Problem:The front label panel on each carton of Hi-Tech
Pharmacal Company's liquid ferrous sulfate product indicates
the contents as "ferrous sulfate solution" and "iron supplement
drops." In the U.S., ferrous sulfate "solution" is not standard
nomenclature. Liquid preparations here include a syrup (18
mg elemental iron per 5 mL), an elixir (44 mg elemental
iron per 5 mL), and drops (15 mg of elemental iron per 0.6
mL). Since the drops have about three times as much iron
as the elixir and about seven times as much as the syrup,
labeling the drops as "solution" could lead to confusion
with the syrup or elixir and a dangerous overdose. One case
of iron overdose was reported.
Recommendation:: Inspect all drug storage areas to
determine if this product is in stock and replace with another
manufacturer's ferrous sulfate drops. FDA and the company
are aware of the problem. Label changes are underway.
- Confusion reported between XELODA and XENICAL (18
Problem:Roche Laboratories, manufacturer of both
XELODA (capecitabine), an antineoplastic agent, and
XENICAL (orlistat), an antiobesity agent, has notified
health professionals about the potential for name confusion
with these products. Although the dosing is significantly
different, both drugs begin with the letters XE, have similar
packaging, and are oral agents.
These drugs should be stored separately. Computer mnemonics
should be based on the generic name. Since the dose and
directions for taking these products differ greatly, educating
patients and printing the drug's name, strength, daily dose,
and the medication's purpose on the prescription can help
to prevent mix-ups.
- HESPAN and heparin mix-ups (18)
Problem:A fatal error occurred when a nurse mistakenly
selected and administered two heparin 25,000 unit per 500
mL premixed bags instead of HESPAN (hetastarch) for a patient
who was actively bleeding. Such mix-ups have been reported
on several occasions to USP, ISMP and FDA. Although this
is primarily a nomenclature issue (both names include the
characters h-e-p-a and n in the same sequence), the drugs
are also found in similar IV bags with blue and red labeling.
Since Hespan may be used in patients who are actively bleeding,
the danger of inadvertent heparin administration is obvious.
Recommendation:Since hetastarch is now manufactured
generically by other companies, consider using an alternate
to Hespan and refer to hetastarch products by generic name.
If Hespan remains in stock, do not store alphabetically
next to premixed heparin products. Label products, storage
bins, and automated dispensing machine pockets with a reminder
about error potential. ISMP has communicated with FDA and
the manufacturer about this serious problem.
II. Misinterpretation or miscommunication of drug orders
- Safe dispensing process needed for patients who can't
swallow NIMOTOP capsules (17)
Problem:NIMOTOP (nimodipine), indicated for
improvement of neurological deficits due to cerebral artery
spasm following subarachnoid hemorrhage, must often be given
via feeding tube to patients who cannot swallow. Although
the manufacturer recommends extracting the Nimotop capsule's
liquid contents into a syringe to facilitate tube administration,
a parenteral syringe is often used and this allows the drug
to be given accidentally by the IV route instead of the
feeding tube if the lines are confused by staff. Several
fatalities have occurred.
Recommendation:Nurses should notify pharmacy when
patients can't swallow. Liquid capsule contents must be
placed into an oral syringe that is prominently labeled
with the route of administration. It is critical for pharmacists
to communicate with nurses about error potential whenever
the drug is dispensed. Computer reminders can be used to
trigger this response and to assure that appropriate warnings
appear on computer-generated medication administration records.
- Hypertonic solutions of sodium chloride injection repeatedly
confused with isotonic products (17)
Problem:Orders for "sodium chloride 0.3% injection"
have been confused with sodium chloride injection 3%.
Recommendation:Use of hypotonic sodium chloride 0.3%
injection by itself could lead to patient harm. The concentration
exists commercially only in combination with dextrose injection.
Prescribers should avoid using items not on the hospital
formulary. Hypertonic sodium chloride injection 3% is available
in most hospitals and has been given in error when 0.3%
is ordered. Hypertonic 3% solutions should be stored only
in the pharmacy to limit access and reduce the potential
for this dangerous mix-up. To assure patient safety, a pharmacist
should review each patient's clinical situation before dispensing
- Clinical personnel must understand physiologic concept
behind peritoneal dialysis (19)
Problem:A child suffered fatal hypernatremia after
receiving specially prepared peritoneal dialysis solutions.
The pharmacist who prepared the dialysate started with a
base solution that already contained a physiologic amount
of sodium. He thought he was adding more sodium to treat
an electrolyte deficiency, as one would by increasing the
amount of sodium in an IV solution. The ordered solution
should have used sterile water for injection (SWFI) as the
Recommendation:Practitioners who treat dialysis patients,
including personnel who prepare solutions, must clearly
understand the physiology underlying peritoneal dialysis.
The patient's serum sodium level tends to equilibrate with
the dialysate's electrolyte concentration during each cycle
of dialysis. Adding sodium ions, while failing to take into
account the physiologic amount of sodium already present
in the commercially available base solution, will lead to
hypernatremia. A clear order to use SWFI as the base solution
also would have prevented this error.
III. Medication delivery device problems
- Proper label placement on syringes can reduce errors with
"IV push" medications (15)
Problem:: Many serious medication errors occur when
the wrong patient receives an "IV push" medication or when
the wrong drug or dose reaches a patient.
Recommendation:Error potential can be reduced by
a labeling technique that places the patient's name, location,
drug, and dose uppermost on the syringe label. When the
label is affixed, flush with the syringe scale, which must
be viewed during injection, important information is easily
visible to the person administering the drug. This provides
additional opportunity to recognize any errors.
- Lack of focus on human factors allows error prone devices
Problem:Practitioners and patients are often blamed
for serious errors that are rooted in poorly designed IV
infusion pumps, patient-controlled analgesia devices, drug
delivery and packaging systems, drug administration tubes
and catheters, etc. Manufacturers and regulatory authorities
often fail to adequately consider user needs and human factors.
Recommendation:Make error potential a factor in device
purchasing decisions. Manufacturers and purchasers must
take into account the possibility of device-related errors
so that error-prone devices may be avoided where possible.
Establish an independent double check system before administration
to detect possible programming errors. Consult with independent
organizations that evaluate medical equipment and review
reports of device-related errors published in the ISMP Medication Safety Alert! and elsewhere.
V. Discussion Items
- Error rates from practitioner reporting are a meaningless
and potentially dangerous way of measuring medication safety
Problem:Hospitals and health systems often rely on
incident reports to "benchmark" or measure their medication
error rates as an indication of the safety of their system.
Yet, by itself, data from hospital incident reports provides
an inaccurate and meaningless way to measure effectiveness
of error prevention strategies. Many actual and potential
errors are either undetected or unreported.
Recommendation:Rates that appear high may actually
reflect a nonpunitive environment that encourages reporting
and facilitates open discussion to improve systems. Criticizing
high error reporting rates instead of rewarding them is
punitive and will suppress the gathering of essential information.
More useful measurement strategies are listed in the ISMP Medication Safety Alert!.
- Four-pronged error analysis (19)
Problem:Excluding analysis of near misses and medication
errors that have happened at other facilities prevents proactive
error reduction strategies. Most often, proactive efforts
are not given high priority. As a result, organizations
may be busy "fighting fires" rather than preventing them.
Recommendation: In addition to examining internal
errors that cause patient harm and analyzing aggregate data,
include a systems review of internal and external errors
that have the potential to cause harm. This fosters less
defensive posturing since the errors have not happened at
your facility. Also, as improvements are made, enthusiasm
builds for identifying, reporting, and analyzing errors
that are actually occurring within the organization. In
the end, discussion about external errors leads to more
effective analysis of internal errors.